In one of the first global clinical trials of its kind, researchers have launched a study to investigate if a diet and exercise program aimed at weight loss can prevent the development of crippling knee osteoarthritis.
The trial will be led by researchers from the University of Sydney and the Kolling Institute in collaboration with an international team from Wake Forest University in North Carolina, Brigham and Women’s Hospital in Boston and the University of North Carolina at Chapel Hill.
The Osteoarthritis Prevention Study or TOPS will compare the impact of a dietary weight-loss, exercise and weight-loss maintenance program with health education in preventing the development of knee osteoarthritis.
The condition is the leading cause of disability among adults, particularly impacting women over 50 who are overweight or obese.
The large-scale clinical trial will be conducted over four years, with participants receiving either a program of regular diet and exercise sessions or a healthy lifestyle program with information sessions, newsletters and text messages.
Internationally recognised rheumatologist, leading University of Sydney researcher and Royal North Shore Hospital clinician Professor David Hunter said the study is one of the first prevention clinical trials which could help people with occasional knee pain reduce their risk of knee osteoarthritis.
“Our trial has come at a time when an increasing number of people are turning to medications like Ozempic or GLP-1 agonists to assist with weight loss and the management of knee osteoarthritis,” he said
“These weight-management medications are a feasible option for managing the condition, but questions remain around safety, cost-effectiveness and the likelihood of weight rebounding.
“Recent investigations by our team indicate that despite the promising results from trials of GLP-1 agonists, lifestyle interventions remain the first-line, safest and most cost-effective approach for people who are overweight, obese or living with knee osteoarthritis.
“Building on that research, our clinical trial will aim to confirm the most effective lifestyle strategies to actually prevent knee osteoarthritis before the condition develops.
“We are looking forward to progressing this valuable area of research and establishing evidenced-based models of care to avoid this increasingly common, disabling condition.”
The research team is now recruiting 320 women who are 50 years or over, who experience little to no knee pain, and who have a Body Mass Index of 30 or more.
The study will involve screening visits over 2–4 weeks and yearly assessment visits over four years, as well as regular diet and exercise or healthy lifestyle classes. Participants will receive long-term support towards achieving a healthy lifestyle.
“Classes are currently available on the Lower North Shore of Sydney and we encourage women who live or work in the area to apply to the program,” said Professor Hunter.
“Depending on the interest, we could look to start classes in other areas of metropolitan Sydney as well,” he said.
Funding has been provided by the National Institutes of Health, the Arthritis Foundation, the University of Missouri, Wake Forest University, and Rapid Nutrition PLC.
This study has been approved by the Northern Sydney Local Health District Human Research Ethics Committee (Ref: 2023/ETH00669).
To find out more about the study, or to join, please click here TOPS Study — Osteoarthritis Clinical Research Group.
You can contact the study team directly with any questions at tops.study@sydney.edu.au